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GE HealthCare scores 510(k) clearance for maternal and fetal monitoring platform

Leave a Comment / Healthcare News / February 5, 2024 / , , , , , , , ,

GE HealthCare received FDA 510(k) clearance for its Novii+ maternal and fetal monitoring solution, which will become available to U.S. customers later in the year. The device, consisting of a wearable and wireless sensor, enables noninvasive measurement and display of fetal heart rate, maternal heart rate and uterine activity for pregnant patients at or beyond …

GE HealthCare scores 510(k) clearance for maternal and fetal monitoring platform Read More »

Zeta Surgical mixed reality navigation gets FDA special 510(k) clearance

Leave a Comment / Healthcare News / January 12, 2024 / , , , , , , , , ,

Surgical robotics and mixed reality company Zeta Surgical announced it secured FDA special 510(k) clearance for advanced functionalities and expanded compatibility of its cranial navigation system for neurosurgery. The mixed-reality navigation system offers surgeons real-time “GPS-like” guidance with millimeter precision. With a computer vision engine ensuring continuous accuracy despite patient movement, the company says the system …

Zeta Surgical mixed reality navigation gets FDA special 510(k) clearance Read More »

Roundup: Nesa gets US FDA 510(k) for fibroid mapping tool and more briefs

Leave a Comment / Healthcare News / July 31, 2023 / , , , , , , , ,

Nesa obtains US FDA 510(k) for fibroid mapping tech Indian femtech Nesa Medtech has received the United States Food and Drug Administration 510(k) clearance for its fibroid mapping tool. Its Fibroid Mapping Reviewer Application assists in the diagnosis and planning of interventional procedures for patients with uterine fibroids. It generates a 3D model of the …

Roundup: Nesa gets US FDA 510(k) for fibroid mapping tool and more briefs Read More »

NeuroRPM obtains FDA 510(k) for Parkinson’s monitoring on Apple Watch

Leave a Comment / Healthcare News / March 26, 2023 / , , , , , , , ,

Digital health technology company NeuroRPM has received FDA 510(k) clearance for its AI-enabled remote monitoring app that utilizes an Apple Watch to track common Parkinson’s symptoms such as bradykinesia, tremor and dyskinesia. Bradykinesia is slowness of movement, and dyskinesia is involuntary or erratic movements.  The Washington D.C.-based company’s algorithms are embedded in the Apple Watch …

NeuroRPM obtains FDA 510(k) for Parkinson’s monitoring on Apple Watch Read More »

Roundup: Dozee, SURGLASSES get 510(k) clearances and more briefs

Leave a Comment / Healthcare News / December 26, 2022 / , , , , , ,

Dozee scores 510(k) for AI contactless sensor for RPM Indian medical device company Dozee has received the United States Food and Drug Administration’s 510(k) clearance for its proprietary contactless sensor for remote patient monitoring. The Dozee sensor sheet, which is placed under a hospital bed mattress, captures micro-vibrations from patients using Ballistocardiography. These vibrations are then …

Roundup: Dozee, SURGLASSES get 510(k) clearances and more briefs Read More »

Seer Medical receives FDA 510(k) for its at-home epilepsy diagnosis aide

Leave a Comment / Healthcare News / September 27, 2022 / , , , , , , , , ,

Australian company Seer Medical received FDA 510(k) clearance for its at-home electroencephalograph (EEG) system Seer Home that helps providers diagnose epilepsy.   Seer Home’s EEG system enables patients to undergo week-long studies at home. Patients wear a device — the Seer Sense — around their shoulders with electrodes connected to the patient’s skull and chest to …

Seer Medical receives FDA 510(k) for its at-home epilepsy diagnosis aide Read More »

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